Process Validation Engineer

Process validation and improvement expertise define this Solution Engineer position supporting Epocal products. Apply statistical tools within regulated medical device manufacturing.Reporting to the Manager, Mechanical Process Engineering, the Solution Engineer develops and executes improvements for Epocal manufacturing. The work includes process validation, process control strategies, experimental design, and quality documentation. You will collaborate with engineering, operations, quality assurance, and external contractors while operating within the Epocal Quality Management System.Key Responsibilities:
Develop and execute manufacturing process improvementsDraft and modify process validation protocolsOrganize validation execution and release corresponding reportsApply statistical techniques to justify proposed improvementsParticipate in root cause and quality initiativesRequirements:
Undergraduate degree in Chemical or Mechanical Engineering desiredMinimum three years of related industrial experienceExperience with regulated process development and validation preferredKnowledge of JMP or Minitab statistical softwareAbility to manage timelines and multiple technical activitiesUse process validation, statistical analysis, and quality systems expertise to improve Epocal manufacturing as a Solution Engineer.
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